Methods and devices for less invasive glenoid replacement

ABSTRACT

The invention relates to a glenoid (shoulder socket) implant prosthesis, a humeral implant prosthesis, devices for implanting glenoid and humeral implant prostheses, and less invasive methods of their use for the treatment of an injured or damaged shoulder.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a continuation of U.S. patent application Ser. No. 14/329,853filed on Jul. 11, 2014, which is in turn a continuation of U.S. patentapplication Ser. No. 12/719,182 filed Mar. 8, 2010, which is acontinuation-in-part application of U.S. patent application Ser. No.11/066,978 filed on Feb. 25, 2005, now issued as U.S. Pat. No.8,007,538. The entirety of these foregoing applications is herebyincorporated by reference herein and made a part of the presentspecification.

FIELD OF THE INVENTION

The present invention relates to the field of glenoid surfacereplacement.

BACKGROUND OF THE INVENTION

The invention provides a glenoid shoulder implant, a humeral implant,and devices for preparing the glenoid and humeral head for jointreplacement.

Shoulder replacement surgery is currently used to treat patientssuffering from disabling pain due to worn or damaged shoulder joints,which can be caused by, e.g., arthritis or injury. The humeral implantscurrently in use are typically made from metal, and the implants areaffixed to the bone using bone cement (e.g., polymethylmethacrylate) orby press fitting the implant into the bone using a roughened outersurface coating on the metal for bony integration. Most glenoid(shoulder socket) implants are made completely from polyethylene andaffixed to the cortical bone using bone cement. Some glenoid implantshave a rigid base plate made of metal, ceramic or rigid polymer with apolyethylene insert. The polyethylene material is suitable as a lowfriction articulating surface for engaging the humeral component.Current glenoid implants are intended to sit on a prepared surface of aglenoid bone. The surface is typically prepared by removing anyremaining cartilage, reaming a smooth bony surface and by drillingreceiving pockets for anchoring features or devices within the naturalglenoid area. Current implant designs use either a keel or multipleelongated pegs on the back (medial surface) of the prosthetic glenoidimplant as anchoring features to secure the glenoid implant inside theglenoid vault.

Glenoid implants with keeled or elongated peg anchors suffer fromseveral disadvantages, which limit their lifespan once implanted andreduce the number of indications for which they can be used. Forexample, these glenoid implants can loosen due to poor fixation to thebone, and are prone to wear and fatigue failure of the polyethylene dueto adhesion, abrasion, and shear stress. Because of these deficiencies,surgeons hesitate to perform glenoid replacement surgery on young ormiddle aged patients with glenoid articular cartilage injuries or damagedue to early arthritis for fear that the implant may not last more than10-15 years in the body, thus subjecting the patient to the possibilityof two or more surgeries during the lifetime of the patient to preservethe function and pain-free state of the joint. Finally, current glenoidimplants with a long keel or an elongated anchor peg are sometimescontraindicated in patients with significant glenoid bone loss. Asarthritis progresses, the humeral head can wear medially and destroy thefoundation of glenoid bone. In these cases, the glenoid vault can besignificantly reduced in volume and depth. Thus, a typical keel or pegdesign can penetrate through the glenoid vault and injure thesuprascapular nerve along the suprascapular notch or spinoglenoid notchwith resultant denervation injury to the rotator cuff muscles.Penetrating through the bone of the glenoid vault can also fracture thebody of the scapula and cause early implant loosening.

There are also several disadvantages associated with current glenoidreplacement surgical techniques. Current techniques require extensiveshoulder exposure with capsular releases in order to fully expose theglenoid surface circumferentially. Since the axillary nerve is locatedwithin 1 cm of the inferior capsule, there is potential risk of axillarynerve injury with resultant denervation injury to the deltoid musclewhen these releases are performed. Use of the current glenoid implantswith keels or elongated anchor pegs requires this extensive glenoidexposure for proper fitting and placement of the prostheses. Currentglenoid replacement surgery also requires a long skin incision,typically 150 mm to 200 mm in length, and extensive soft tissuestripping in order to fully expose the glenoid circumferentially, whichincreases the risk of tissue damage and produces a cosmeticallyunappealing scar. Finally, current glenoid replacement surgicaltechniques require advanced surgical training and expertise within thespecialty of shoulder surgery, yet the majority of shoulder implantsperformed in the U.S. every year are performed by orthopedic surgeonswho do not have advanced training in the subspecialty of shouldersurgery. Therefore, many surgeons have difficulty preparing the glenoidsite for a total shoulder replacement using the current techniques.

As a consequence of the limitations of the currently available designsand surgical techniques some patients forego surgery and incur a risk ofcontinued pain and disability. Patients who elect a surgical solutionincur the risk of neurovascular injuries, glenoid and scapula fractures,and failed shoulder prostheses requiring revision surgery. Thus, thereremains a need for an improved glenoid implant and improved methods forperforming replacement shoulder surgery.

SUMMARY OF THE INVENTION

There is provided in accordance with one aspect of the presentinvention, a method of treating a patient. The method comprises thesteps of identifying a patient having a glenoid surface, and reaming acavity into the glenoid surface. A glenoid implant is inserted into thecavity, such that at least a portion of a peripheral edge of the implantresides below the adjacent glenoid surface, and the portion residingbelow the adjacent glenoid surface is circumferentially surrounded bythe cortical bone of the glenoid.

The reaming a cavity step comprises reaming a circular cavity so as tocreate a mating surface for the prosthetic glenoid implant, said surfacebeing below the native glenoid bone surface and being circumferentiallysurrounded by native glenoid bone. The inserting a glenoid implant stepmay comprise fitting a glenoid implant having a circular portion intothe cavity, said circular portion having a diameter complimentary tothat of the cavity reamed in the glenoid bone

The method may additionally comprise the step of securing the implantwithin the cavity using bone cement or mechanical engagement such as canbe achieved using a press-fit interference or bone screws. The implanthas a medial surface disposed to engage the prepared surface within thereamed cavity. Various configurations of this medial surface arepresented, these surface geometries being configured to receive bonecement and improve adhesion of the implant to, and retention within, thereamed bone cavity.

The method may additionally comprise the step of stabilizing the implantwithin the cavity using a central peg extending from a medial surface ofthe implant, said peg being located within a prepared receiving hole inthe glenoid bone Various geometric configurations of this peg arepresented.

The method may additionally comprise the step of accessing the glenoidvia a deltopectoral approach. Alternatively, the method may comprise thestep of accessing the glenoid via an anterolateral approach.

In certain implementations of the invention, the reaming a cavity stepcomprises reaming a cavity completely within the boundary of the nativeglenoid cavity, without destroying the peripheral margin of the glenoidsurface. This step may be accomplished while leaving the majority of theinferior capsule intact. The reaming a cavity step may comprise reaminga cavity while leaving the peripheral cortex intact. The method mayinclude the step of accessing the glenoid surface via an incision havinga length of no more than about 9 cm.

In the patients having more extensive deficiency of glenoid bone thereis often a need to reconstruct the natural geometry of the shoulder soas to restore the natural orientation and engagement of the humerus toglenoid interface. This is often currently achieved by grafting bonetissue or otherwise reconstructing the bony geometry of the glenoidstructure. In one aspect of the glenoid prosthesis invention disclosedherein there is a circular prosthesis configuration presented whereonthe plane of the articulating surface is offset from the plane of themedial, bone engaging, surface of the implant. The combination of acircular implant and included angles between the medial and articulatingsurfaces of the implant device allows for in-situ positioning of theimplant by rotating the circular implant around the central axis of themedial surface in order to restore the natural plane of the glenoidvalue.

In certain patients there is extreme bone deficiency or there exists anatypical bone wear pattern, in these case there may remain insufficientbone in which to create a reamed cavity which completely surrounds theperimeter of the glenoid implant. In one implementation the inventedglenoid implant device has an annular ring disposed around thecircumference of the medial surface. During the cavity reaming step ofthe surgical procedure a perimeter groove is cut into the glenoid bonestructure around the circumference of the reamed cavity so as to createa receiving channel around the perimeter of the reamed cavity in thebone, this groove receives within it a corresponding annular ring of theglenoid implant device thereby creating full circumferential engagementof the implant within the bone in order to increase the retention andstability of said implant.

There is further presented a geometry for the articulating surface ofthe device which permits a semi-constrained relationship between theglenoid implant device and the humeral head.

In accordance with a further aspect of the present invention, there isprovided a glenoid implant. The implant comprises a circular body,having a medial surface, an articulating surface, a peripheral edge andcentral axis. A post is provided on the medial surface, disposedconcentrically on the central axis. At least one axially extendingflange extends from the medial surface at the peripheral edge of thecircular body.

Preferably, the at least one flange extends around at least about 75% ofthe peripheral edge of the circular body. The flange may extend at leastabout 85% or 95% of the way around the peripheral edge of the circularbody, and may be discontinuous or continuous.

The circular body has a first thickness measured in the axial directionat a first point on the peripheral edge, and a second thickness measuredin the axial direction at a second point on the peripheral edge which isspaced apart from the first point by 180°. In one implementation of theinvention, the first thickness is substantially equal to the secondthickness. Alternatively, the first thickness may be at least about 125%of the of the second thickness, at least about 150% of the secondthickness, or at least about 200% of the second thickness to provide anangled, rotationally adjustable implant.

In accordance with a further aspect of the present invention, there isprovided a glenoid implant. The implant comprises a circular body,having a medial surface, an articulating surface, a peripheral edge anda central axis. A post is provided on the medial surface, disposedconcentrically on the central axis. The body comprises a first thicknessmeasured in the axial direction at a first point on the peripheral edge,and a second thickness measured in the axial direction at a second pointon the peripheral edge, spaced apart from the first point by 180°. Thefirst thickness is at least about 125% of the second thickness. Theimplant may additionally comprise at least one projection extendingaxially from the body at the peripheral edge. The projection maycomprise an annular flange, which may be continuous or discontinuous.The implant may additionally comprise at least one bone cement flowchannel on the medial surface.

In accordance with a further aspect of the present invention, there isprovided a method of treating a patient. The method comprises the stepsof exposing a glenoid surface, and reaming a circular depression in theglenoid surface. A glenoid implant is provided, having a circularperipheral edge and a non-spherical concavity with an articulatingsurface, the concavity having an axis of rotation which is angularlyoffset from an axis of the circular peripheral edge. The implant ispositioned such that the circular peripheral edge at least partiallyresides within the circular depression. The implant is thereafterrotated, to direct the axis of rotation of the articulating surface to adesired position.

In accordance with a further aspect of the present invention, there isprovided a method of treating a patient. The method comprises the stepsof making a skin incision, and exposing a glenoid surface through theincision. A reamer is introduced through the incision, and a circulardepression is reamed within the glenoid surface. The glenoid implant isintroduced through the incision, and positioned at least partiallywithin the depression. The incision is preferably no more than about 100mm in length.

In accordance with a further aspect of the present invention, there isprovided a cement construct, for retaining an implant within a cavity ina bone. The construct comprises a cement shell, having a concave sidecorresponding to the configuration of an implant and a convex sidecorresponding to the configuration of a prepared cavity in a bone. Theconcave side has an axis of rotational symmetry. A first tubular wallsection is concentrically disposed about the axis, and a substantiallyplanar section extends radially outwardly from an end of the firsttubular wall section and transverse to the axis.

A second tubular wall section is concentrically disposed about the axis,and extends axially from a peripheral edge of the planar section. Thesecond tubular wall section extends at least about 180°, preferably atleast about 270°, and in certain implementations completely around theaxis.

In accordance with another aspect of the present invention, there isprovided a method of preparing a glenoid surface for implantation of aglenoid implant. The method comprises the steps of reaming a circulardepression in the glenoid surface, to produce a reduced glenoid surfacehaving an axis of rotation. A bore is reamed coincident with the axis,and below the level of the reduced surface. An annular channel is reamedconcentrically about the axis, and below the level of the reducedsurface.

Further features and advantages of the present invention will becomeapparent to those of skill in the art in view of the detaileddescription of preferred embodiments which follows, when consideredtogether with the attached drawings and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is an anterior surface view of the circular glenoid implant ofthe invention.

FIG. 1B is an anterior surface view of the oval glenoid implant of theinvention.

FIG. 1C is a backside view of the circular glenoid implant of FIG. 1A

FIG. 2A is an anterior surface view of the circular glenoid implant ofthe invention that includes a single short backside peg.

FIG. 2B is a backside view of the circular glenoid implant of FIG. 2B.

FIG. 3 is an anterior (frontal) view of a typical prior art glenoidimplant with a keel design situated in the glenoid.

FIG. 4 is an anterior (frontal) view of a scapula containing a typicalprior art glenoid implant with a multiple peg design situated in theglenoid.

FIG. 5 is a backside view of a scapula containing a typical prior artpegged glenoid implant which was removed from a patient.

FIG. 6 is a lateral view of the prior art pegged glenoid implant of FIG.5.

FIG. 7 is an anterior (frontal) view of a scapula containing an insetglenoid implant of the invention situated in the glenoid.

FIG. 8A is an anterior surface view of a typical prior art glenoidimplant.

FIG. 8B is an anterior surface view of the circular glenoid of theinvention.

FIG. 9A is a backside view of a typical prior art keeled glenoid trialimplant.

FIG. 9B is a backside view of the circular glenoid of the inventionshowing a short backside peg.

FIG. 10A is a surface view of the glenoid bone with an inset circularglenoid implant of the invention.

FIG. 10B is a surface view of the glenoid bone with an inset ovalglenoid implant of the invention.

FIG. 11 is a surface view of the glenoid bone with a typical prior artonlay glenoid implant, which does not sit inset to the glenoid bone.

FIG. 12 is a photograph of a model depicting the glenoid (G), scapula(S), clavicle (C), Acromio-Clavicular Joint (AC), and Coracoid (Co). Theglenoid is shaded to designate the placement surface for the glenoidimplant of the invention.

FIG. 13 is a view showing the use of a straight drill of the prior artfor preparing the glenoid for implantation.

FIG. 14 is a view of the 90° drill of the invention.

FIG. 15 is an anterior (frontal) view of the scapula showing the use ofthe 90° drill of the invention.

FIG. 16 is a view of the reamer of the invention.

FIG. 17 is frontal view of the humeral cutting jig of the invention

FIG. 18 is side view of the humeral cutting jig of FIG. 17 placed inposition on a humerus. The cutting jig can be secured by K-wires(shown), pins, or screws.

FIG. 19 is a view of the humerus and humeral cutting jig of FIG. 18after resection of humeral head along the axis of the cutting jig.

FIG. 20A is an anterior (frontal) view of the humeral implant of theinvention.

FIG. 20B is a lateral view of the humeral implant of the invention.

FIG. 20C is an anterior (frontal) view of the humeral implant of theinvention with a collar.

FIG. 20D is a lateral view of the humeral implant of the invention witha collar.

FIGS. 21, 22, and 23 are photographs showing the inset circular glenoidimplant of the invention implanted in the glenoid of a patient.

FIG. 24 is a photograph showing the 15 cm incision from a typical priorart total shoulder replacement surgery.

FIG. 25 is a photograph showing the 9 cm incision from the“mini-incision” total shoulder replacement surgery of the invention.

FIG. 26A is a view showing a right angle drill attachment for use inpreparing a glenoid for implantation of a glenoid implant.

FIG. 26B is a view showing a drill with the right angle drill attachmentand drill bits for use in preparing a glenoid for implantation of aglenoid implant.

FIG. 27 is perspective view of the medial aspect of a circular glenoidimplant, showing a geometry of the medial and perimeter surfaces of thedevice configured to receive and distribute bone cement.

FIG. 27A is a partial cross sectional view of a circular glenoid implanttaken along the line 27A-27A in FIG. 27.

FIG. 27B is a cross sectional view of a circular glenoid implant locatedwithin a reamed receiving cavity in bone tissue and being encased andanchored therein by bone cement.

FIG. 28 is a cross sectional perspective view of a glenoid implant,illustrating the interconnected bone cement receiving geometry of themedial and circumferential surfaces.

FIG. 29 is a bottom plan view of the medial surface of a glenoidimplant, illustrating the interconnected bone cement receiving geometryof the medial and circumferential surfaces.

FIG. 30 is a perspective view of a reamed native glenoid bone, showing areamed cavity within the bone

FIG. 31 is a perspective view of a reamed cavity in glenoid bone, theglenoid structure exhibiting bone deficiency.

FIG. 32 is a perspective view of the medial aspect of a circular glenoidrepair device.

FIG. 33 is a perspective view of a reamed cavity in glenoid bone, theglenoid structure exhibiting bone deficiency. FIG. 33 furtherillustrates the reamed cavity having an annular recess at thecircumference to receive a corresponding protruding feature of aprosthetic glenoid device.

FIG. 34 is a cross sectional view of reamed glenoid bone, showing theview 34-34 of FIG. 33.

FIG. 35 is a perspective view of an alternate embodiment of the medialaspect of a circular glenoid repair device, having localized protrusionsat a radius corresponding to that of the reamed circumferential grooveof FIG. 33.

FIG. 36 is a cross sectional view of a circular glenoid implant showingan articulating surface which is offset from the medial surface by anincluded angle.

FIG. 37 is a perspective view of a circular glenoid implant showing anarticulating surface which is offset from the medial surface by anincluded angle.

FIG. 37A is a perspective cross sectional view of a circular glenoidimplant having an articulating surface which is offset from the medialsurface by an included angle, the articulating surfaces having a visibleindicator to identify the apex of the articulating surface of thedevice.

FIG. 37B is a perspective view of a circular glenoid implant having anarticulating surface which is offset from the medial surface by anincluded angle, the articulating surfaces having visible graduatedindicia to identify the apex of the articulating surface of the deviceand to aid in angular positioning of the implant device.

FIG. 38 is an elevational cross sectional view of a circular glenoidimplant having offset medial and articulating surfaces and furtherillustrating an axis of rotation for positioning the implant devicewithin the reamed receiving cavity in the glenoid bone.

FIG. 39 is an elevational cross sectional view of a circular glenoidimplant having offset medial and articulating surfaces, the articulatingsurface being generated by an arc of constant radius with an originoffset from the axis of revolution, and further illustrating an axis ofrotation for positioning the implant device within the reamed receivingcavity in the glenoid bone.

FIG. 40 is an elevational cross sectional view showing the articulatingsurface resulting from a constant radius arc with an origin offset fromthe axis of rotation being rotated about the axis of rotation.

FIG. 41 is an illustration of an exemplary embodiment of an offsetsurface design.

FIG. 42 is a cross sectional perspective view of a glenoid repair devicehaving the plane of the articulating surface angularly offset from theplane of the medial surface, the articulating surface being anon-spherical surface of revolution of a constant radius arc.

FIG. 43 is a cross sectional view of a glenoid repair device having anon-spherical surface of constant radius, engaging various humeral headconfigurations.

FIG. 43A is a cross section view of a glenoid repair device having anon-spherical surface, the articulating surface having a fixation portbetween the articulating surface and the medial surface and a mechanicalfastener inserted there through into native bone.

FIG. 43B is a cross sectional view of a glenoid repair device having anon-spherical articulating surface, and a fixation port between thearticulating surface and the medial surface, the medial surfaceincluding an expandable anchor post with a locking element beinginserted into the fixation post through the articulating surface tolaterally expand the anchor post elements on the medial surface.

FIG. 44 is a cross sectional view as in FIG. 43, further illustratingthe engagement of various humeral head configurations.

FIG. 45 is a perspective view of the medial aspect of a circular glenoidrepair device, showing an alternate implementation of the central anchorpeg.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The invention features an inset glenoid implant prosthesis, a humeralimplant prosthesis, and methods and devices for preparing the surgicalsite for implantation of the implant prostheses.

In one aspect, the invention features an inset glenoid shoulder implantthat is implanted within the glenoid vault, thereby allowingcircumferential cortical support along the rim of the prosthesis, whichimproves fixation strength in comparison to current glenoid implants.Another advantage of the glenoid implant is that it requires only aminimal amount of bone removal for implantation.

The glenoid implant itself includes a (1) body portion having (i) asmooth concave lateral articulating surface facing away from thescapula, which is adapted to be engaged by a convex surface of a humeralcomponent, and (ii) an opposing surface on the medial side intended tobe positioned within a cavity reamed in the glenoid. In a preferredembodiment, the glenoid implant also includes (2) a short peg on themedial side extending centrally outward along an axis from a convex orflat backside (medial) surface of the glenoid implant. In a preferredembodiment, the short peg of the glenoid implant is less than about 10mm long, more preferably about 8 mm or less in length, even morepreferably about 5 mm or less in length. Alternatively, the glenoidimplant has multiple pegs, each of which can be the same length ordifferent lengths, e.g., less than about 8 mm or less in length, morepreferably about 5 mm or less in length. In another embodiment, at leastone of the pegs is between about 5 mm and about 8 mm in length and theremaining pegs are less than about 8 mm in length.

In another preferred embodiment, the body portion extends to an edgehaving a circular configuration while, in a second embodiment, the bodyportion has an edge defining a non-circular configuration, such as anoval, an elongated configuration, or a configuration which may becharacterized as rectangular with slightly rounded ends. In anotherpreferred embodiment, the glenoid implant is implanted in a preparedcavity of the glenoid which conforms generally to the backside (medial)surface only and sits inset slightly within the glenoid vault. Inanother preferred embodiment, the glenoid implant is implanted in aprepared cavity of the glenoid which conforms generally to the singleshort peg or multiple short pegs, if present, and the backside (medial)surface of the glenoid implant.

In another preferred embodiment, the glenoid implant of the invention ismanufactured using polyethylene, metal, or ceramic, or combinationsthereof, e.g., a combination of metal and polyethylene or ceramic andpolyethylene.

In another preferred embodiment, the glenoid implant of the invention issecured to the glenoid using cement fixation or press fit technique. Inyet another preferred embodiment, the glenoid implant is further securedto the glenoid using screws, e.g., in press fit designs.

In another preferred embodiment, the glenoid implant can be customizedduring the surgical procedure, as is required based on the condition ofthe patient. In another embodiment, the glenoid implant is sterilizedprior to implantation. In yet another embodiment, the glenoid implant isprovided in sterile packaging.

In the method of implanting the glenoid component, the first step afterexposing the glenoid cavity is to determine the appropriate size ofcomponent to be used. This is done by placing a series of circularsizers having varying diameters over the glenoid cavity to determine theproper diameter to which the scapula should be reamed at the surfacedefining the glenoid cavity and the proper size of glenoid component.Using a combined sizer/guide having a central hole and passageway formedtherein to determine the correct location and attitude, a hole isdrilled a few millimeters into the scapula through the glenoid surfaceusing a combined guide wire/drill. The guide wire/drill is calibrated inorder to readily determine the depth of drilling and is attached to achuck if a power drill is used or a T-handle or the like if the drillingis manual. The guide wire/drill should be drilled into the scapulasubstantially perpendicular to the anatomic axis of the glenoid surface.Thereafter, the combined sizer/guide is removed and a reamer ispositioned to ream the scapula to the proper shape and depth forming acavity having a circular cross-sectional configuration for a circularimplant or an oval configuration for an oval implant in a plane normalto the axis defined by the guide wire.

In another aspect of the invention, the glenoid implant can be used inpatients with deficient glenoid bone due to fracture or severearthritis. In preferred embodiments, the glenoid implant has none, one,two, or three or more short backside pegs that do not extend beyondabout 10 mm outwardly from the backside (medial) surface of the glenoidimplant. In a preferred embodiment, the peg or pegs do not extend beyondabout 8 mm from the backside (medial) surface of the glenoid implant.Because the glenoid implant lacks a long backside extension, it can besafely placed inside a glenoid vault with minimal depth. This minimizesthe risk of fracturing the body of the scapula or injuring thesuprascapular nerve or rotator cuff.

Another aspect of the invention features a humeral implant for use in atotal shoulder replacement procedure. The humeral implant of the presentinvention is less than 70 mm in length, preferably about 60 mm inlength, and is less than 40 mm wide anterior to posterior (preferably 20to 30 mm wide). In an embodiment, the humeral implant includes a collar,which prevents the humeral implant from embedding too deeply in thehumerus. In other embodiment, the humeral implant includes a flange(fin), which provides fixation of the humeral implant in the medial tolateral plane and rotational control. Alternatively, the humeral implantcan contain 3 flanges (fins) with 1 lateral, 1 anterior, and 1posterior. The stem of the humeral implant defines a longitudinal axisand the planar surface extends from between about 45° to about 60° tothe axis of the stem. The proximal end of the stem includes a bore thatextends downward from the planar surface and is adapted to be engaged byan artificial humeral head by means of a morse taper. In otherembodiments, the humeral implant is fixed using a bone cement, such aspolymethylmethacrylate (PMMA) or a compatible fixation material, or itis press-fit without bone cement. The humeral implant can be customizedduring the surgical procedure, as is required based on the condition ofthe patient. In another embodiment, the humeral implant is sterilizedprior to implantation. In another embodiment, the humeral implant isprovided in sterile packaging. In another preferred embodiment, thehumeral implant of the invention is manufactured using polyethylene,metal, or ceramic, or combinations thereof, e.g., a combination of metaland polyethylene or ceramic and polyethylene.

Another aspect of the invention features a cutting jig for preparing ahumerus for replacement by a humeral implant. The humeral head cuttingjig is a simple, low profile humeral cutting jig that can be a fillcircle or part thereof. The cutting jig is placed along the anatomicneck of the humerus in the appropriate version (angle of the cut) asdetermined by the surgeon. The cutting jig can be secured along theanatomic neck of the proximal humerus using K-wires, pins, or screws andis removed after completion of humeral head resection. In an embodiment,the cutting jig includes a handle portion.

Another aspect of the invention features a method for providing ashoulder implant which can be performed through a minimal incisiontechnique (“mini-incision”). Instead of an extensive deltopectoralapproach involving extensive soft tissue stripping, capsular releases,and circumferential glenoid exposure, this inset implant can beperformed through a more limited mini-incision technique. Amini-deltopectoral incision is utilized. The skin incision is shorter,and the pectoralis tendon is left intact. The majority of the inferiorcapsule is also left intact. In a preferred embodiment, the glenoidlabrum can be left intact if this is preferred by the surgeon. Thecentral portion of the glenoid bone is then reamed while leaving theperipheral cortex intact. There are three major consequences of thismini-incision technique:

1—Shortening the length of the incision and exposure provides a morecosmetic incision for the patient.

2—Avoiding an extensive inferior capule incision increases the safety ofthe procedure by reducing the risk of injury to the axillary nerve.

3—Providing an implant that can be placed in the glenoid withoutextensive, circumferential glenoid exposure would allow generalorthopedists to perform a shoulder replacement with less difficulty andpotentially fewer complications.

The present invention is also directed to a method for implanting suchglenoid implant for precise placement in the scapula and precisedrilling and reaming of the scapula. The method is performed using aspecialized power drill having a lateral drilling attachment and a shortdrill bit incorporated into the attachment, which is used to drill acentral hole in the glenoid surface. The bone is then reamed with areamer bit attached to the drill. The lateral drilling attachmentinclines the axis of the drill relative to the axis of the accesspathway by an angle within the range of from about 45° to about 110°,often within the range of from about 50° to about 90°, and, in oneimplementation about 60°.

Another aspect of the invention features a slim design power drill forpreparing a glenoid for implantation of a glenoid implant, in which thepower drill includes a right angle drilling attachment having anextension rod with a length of at least 10 cm, more preferably at least12, 15, or 18 cm long, the end of which is includes a collet or chuckthat is positioned at a 90° angle relative to the extension rod andwhich is adapted to receive a short drill bit; the power drill beingprepared for use in the surgical field by sterilization. In a preferredembodiment, the drill and accessories are sterilized and provided in asterile container. In other preferred embodiments, the drill bit is 10mm long, more preferably 12, 14, 16, 18, or 20 mm long, and mostpreferably 25, 35, 45, 55, 65, or 75 mm long. In other preferredembodiments, the drill bit has the following diameters: 1.5 mm, 2.5 mm,3.0 mm, 3.2 mm, 4.0 mm, 4.5 mm, 5.0 mm, 5.5 mm, 6.0 mm, 6.5 mm, 7.0 mm,8.0 mm, 9.0 mm, or 10.0 mm. The power drill is designed to allowdrilling in spaces as tight as 50 mm. In other preferred embodiments,the overall length of the right angle drilling attachment is 18 cm, morepreferably 20 cm, most preferably 22 cm. The head width and extensionrod diameter are preferably less than 25 mm, more preferably less than22 mm, and most preferably less than 20 mm. The head length ispreferably less than 30 mm, more preferably less than 28 mm, and mostpreferably less than 25 mm. In other preferred embodiments, the rightangle drilling attachment is designed to be attached to any power drill,the use of which is acceptable in a surgical field, and is designed tobe lightweight, e.g., less than about 200 grams, more preferably lessthan about 180 grams, and most preferably less than about 150 grams. Thepower drill can be powered using a battery supply (cordless) or it canbe powered using an electrical cord powered from a standard electricaloutlet. See, e.g., U.S. Pat. No. 6,037,724, incorporated herein byreference.

The design of the glenoid implant of the invention provides increasedimplant fixation strength to glenoid bone and therefore decreases therate of glenoid implant loosening. This implant is also designed for usein cases of deficient glenoid bone which would preclude the use of acurrent glenoid implant since they require adequate bone in the glenoidvault to support multiple long pegs or a keel.

The invention also features a humeral implant, which is less than 70 mmin length, preferably about 60 mm in length, and is less than 40 mm widefrom anterior to posterior (preferably 20-30 mm). The humeral implant ofthe invention is significantly shorter and thinner (in the anterior toposterior dimension) than most current stems, which are about 70-115 mmin length and bulkier in the proximal (metaphyseal) area than distallyboth in the anterior to posterior dimension and medial to lateraldimension. Because the humeral implant of the invention is shorter, itcan be implanted in a narrower metaphyseal area and does not require theremoval of a significant amount of bone. Fixation of the present humeralimplant depends upon good interference fixation in the medial-lateralplane when press fit (similar to some current total hips). The humeralimplant can be fixed using a bone cement, such as polymethylmethacrylate(PMMA) or a compatible fixation material. Alternatively, the humeralimplant can be press-fit.

The invention also features a minimal incision shoulder arthroplastytechnique that allows replacement of the glenoid surface and humeralhead with only a small incision and less extensive soft tissuestripping. The “mini-incision” procedure also leaves the pectoralistendon and the majority of the inferior capsule intact. The glenoidlabrum can also be left intact. The central portion of the glenoid boneis then reamed while leaving the peripheral cortex intact. Theadvantages of this “mini-incision” procedure include a shorter incisionwith less scarring, increased safety, and a more simple exposure of theglenoid, thus allowing general orthopedists to perform a shoulderreplacement with less difficulty and potentially fewer complications.

The glenoid implant of the invention lacks a keel and multiple longpegs, which are typically present in the prior art glenoid implants.Instead, the glenoid implant of the invention optionally includes one ormore pegs or flanges disposed radially symmetrically about a centralaxis of the implant, such as only a single short (less than about 8 mm),central backside peg which stabilizes the glenoid implant. The glenoidimplant of the invention does not require a long extended keel or longpegs because the majority of the fixation strength is concentrated onthe rim of the embedded implant. This obviates the need for significantbackside fixation. The fixation, with either cement or press fittechniques, offers circumferential cortical bone fixation around theprosthesis. The shear stresses placed on the implant are thereforesupported by a circumferential buttress of bone, which is moremechanically sound than an onlay prosthesis with an extended backsidekeel or multiple long pegs.

An object of the invention is to minimize the common complications ofglenoid implant loosening and fatigue failure that exist with currentglenoid implants. All previous glenoid implants sit on the surface of areamed articular surface and utilize a keel or multiple pegs to securethe implant inside the glenoid vault (see, e.g., FIGS. 3-6). Thisinvention features a glenoid implant (which can be polyethylene, metal,ceramic, or combinations thereof) that is not designed to be placed onthe surface of the reamed glenoid articular cartilage. Rather, thepresent implant is designed to be inset partially (e.g. at least about 1mm or 2 mm or 3 mm or 4 mm or more below the native adjacent surface ofthe bone at at least one point around the circumference of the implant)or fully within the glenoid vault (see FIG. 7). The implant may be pressfit or cemented in the reamed cavity within the glenoid bone.

Patients who can benefit from the use of the glenoid implant of theinvention and the improved methods for performing a total shoulderarthoplasty include young, middle, and older patients with arthritis(typical total shoulder replacement (TSR) patients) or damage or injuryto the shoulder. This new inset glenoid implant allows TSR surgery fornew, previously contraindicated applications, including applications inwhich the patient presents with bone defects on the glenoid. The glenoidimplant of the invention can also be utilized in revision surgeries.

Referring now to FIGS. 1A, 1B, and 1C, there is provided glenoid implant10, which is intended to be implanted in the glenoid as part of a TSRarthroplasty. Glenoid implant 10 replaces the natural glenoid cavity(see G of FIG. 15) and provides a bearing surface against which the headof a humerus or humeral component may articulate. Glenoid implant 10includes concave articulating surface 14 and convex or flat backsidesurface 16, which can, optionally, include roughened or textured surface18. Glenoid implant 10 can be provided as a circular design (FIGS. 1Aand 1C) or as an oblong, oval design (FIG. 1B).

Referring now to FIGS. 2A and 2B, glenoid implant 10 can include short,backside peg 12 on the medial, convex or flat backside surface 16 ofglenoid implant 10. Short, backside peg 12 is situated centrally on themedial (back) side of glenoid implant 10 and is preferably a cylindricalpeg shape that extends outwardly from glenoid implant 10 away from theback of the implant 16.

Glenoid implant 10, including or excluding short, backside peg 12, isadapted to be implanted in a prepared cavity of the glenoid (see, e.g.,FIG. 12), such that it is partially or fully inset to the cortical boneof the glenoid, and is retained with bone cement or using press-fittechniques. Glenoid implant 10 can be further secured to the glenoidusing one or more screws.

Glenoid component 10 of the present invention includes concave lateralarticulating surface 14 against which the head of a humerus or humeralcomponent moves. Glenoid implant 10 is manufactured using a suitablematerial, for example, polyethylene, metal, ceramic, or combinationsthereof, with lateral articulating surface 14 being smoothly contoured.The radius of curvature of the articulating glenoid surface can matchthe humeral head surface or it can be slightly larger than the radius ofcurvature of the humeral head implant.

In preferred embodiments, glenoid implant 10 has a lateral articulatingsurface 14 having a concave circular or oval surface encircled bycircular edge 20. The implant at the circular edge 20 has a thickness inan axial direction in the range of about 3-6 mm, preferably about 3 mm.The peripheral edge will have a greater axial dimension in embodimentssuch as illustrated in FIG. 32 which includes an additional axiallyextending annular flange.

The medial, back side of glenoid implant 10 is preferably roughened ortextured. For example, glenoid implant 10 can include a series ofelongated groves 18 in multiple locations for receiving bone cement toassist in the cement augmentation and retention of glenoid implant 10.

In preparing the glenoid to receive glenoid implant 10, the glenoid (G;see, e.g., FIG. 12) is reamed to receive all or a portion of glenoidimplant 10 so that glenoid implant 10 is circumferentially surrounded bycortical bone of the glenoid (G), which aids in the stabilization andsecurity of glenoid implant 10.

Referring now to FIGS. 13-16, there will be described a method forpreparing a cavity in the glenoid for receiving a glenoid implant of thepresent invention and apparatus to be used therewith.

In preparing the cavity in the glenoid (G) to receive glenoid implant10, the surgeon will initially determine the position of the drill siteusing a guide known in the art (see, e.g., U.S. Pat. Nos. 6,712,823;6,364,910; 5,030,219; and 5,489,310; all of which are incorporated intheir entireties by reference herein).

A reamer of appropriate size is then chosen based on the size of thesizer guide previously chosen. The reamer has a symmetrical head with aplurality of cutting blades and may have a peripheral stop surface. Thepreviously drilled hole is used as a center guide for the reamer. Thereamer is used to create a cavity in the glenoid surface of the scapulain which the prosthetic glenoid component will be installed. The reamedcavity is a receiving cavity for the glenoid repair device and is of ageometry that is generally complimentary to the geometry of the medialand peripheral aspects of the glenoid repair implant After the cavityhas been created, the glenoid repair device is installed within thereamed bone cavity, with or without the use of bone cement. Insertionmay be achieved by manually placing the repair device through theincision into the cavity within the bone or by means of an elongatedinsertion device so as to permit easy location, guidance andmanipulation of the repair device through the incision and into andwithin the reamed bone cavity.

A method for implanting glenoid implant 10 will now be described withreference to FIGS. 13-16. Initially, if a total shoulder arthroplasty isperformed, a humeral implant having a head portion, discussed below, anda glenoid implant are implanted. Prior to implantation of the humeralcomponent into the humerus, glenoid preparation begins. With the glenoidcavity (G) of the scapula (S) exposed, an alignment or pilot hole isfirst drilled substantially in the center of the glenoid cavity (G)using, e.g., the drill shown in FIGS. 14, 15, and 26. Once the pilothole is drilled, the glenoid cavity (G) is reamed using a glenoidsurface rasp (see bit attached to the drill depicted in FIG. 16)attached to a reamer shaft with a driver having a laterally directed(e.g. 90°) distal end (see FIG. 26). The glenoid surface rasp mayinclude a guide pin and a roughened cutting surface to create a troughfor the glenoid component. The 90° angle of the shaft of the driverpermits drilling in tight glenoid cavities. Thus, the procedure can beperformed in a minimally invasive manner because it does not requirefull circumferential exposure of the glenoid, nor does it require acomplete capsular release. The 90° shaft of the drill includes aquick-connect attachment which receives the quick-connect drill bit. Thereamer is rotated by suitable power means or by hand to ream the glenoidcavity. Following such reaming, the reamer and the guide wire/drill areremoved leaving a cavity which is wholly contained within the glenoidcavity (G).

Once the holes have been drilled and the glenoid reamed, a confirmationstep is performed in which a provisional or surrogate glenoid implant(often called “a trial”) may be used prior to cementing the finalglenoid implant to verify placement, range of motion, and glenoid size,and to verify that the glenoid implant is sufficiently inset within thebone. Several iterations of this step may occur, in which varioussurrogate implant devices are tested in-vivo in order to select apreferred implant geometry. After the preferred glenoid implant has beenselected, the surrogate implant is removed. In instances where thesurgeon elects to insert the implant within the reamed bone cavity asuitable bone cement, such as polymethylmethacrylate (PMMA) or othercompatible material, is placed in the reamed bone cavity of the glenoidvault and may also be applied to the medial (back) surface of glenoidimplant 10. Glenoid implant 10 is then positioned within the preparedcavity. If a cemented construct has been chosen, the glenoid implant 10is then held in place until the cement hardens to assure strong fixationof glenoid implant 10 in the scapula. The head portion of the humerus orhumeral component may then engage the concave articulating surface ofthe glenoid implant 14.

As can be appreciated, the reaming is contained completely within theboundary of the glenoid cavity (G) and therefore does not destroy theperipheral margin of the glenoid surface. Additionally, as can be seenin FIG. 7, there is preferably a slight overhang of glenoid implant 10beyond the margin of the natural glenoid cavity.

This method can be performed using a deltopectoral or anterolateralsurgical approach. For most cases, a limited deltopectoral incision willbe adequate to allow exposure to all involved structures. Use of glenoidimplant 10 in the shoulder arthroplasty procedure allows the surgeon touse a “mini-incision technique,” similar to techniques utilized fortotal knee surgery and total hip surgery. Typical incision sizes forcurrent Glenoid repair procedures are in the range of 150 mm to 200 mm,use of the methods and devices disclosed herein permits a typicalincision size in the range of 70 mm to 100 mm to be used. Further, theuse of the glenoid implant 10 reduces the number of surgical steps,entries into the wound and has other surgical benefits as outlined inTable 1. Thus, the glenoid reaming and insertion of the glenoid trialand/or final glenoid implant as described herein may be accomplished viaan incision of no more than about 100 mm, preferably no more than about90 mm and in some embodiments of the invention, no more than about 80mm.

TABLE 1 Comparison of surgical procedures for Current and Less InvasiveGlenoid Replacement Less Invasive Standard surgical Glenoid approachapproach, Incision size 15-20 cm 7-10 cm Deltopectoral Yes Yes incisionSubscap incision Yes Yes Capsule wide Yes No (only incision excision ofcapsule) Labral incision Yes No Biceps release Yes Only if needed Fullinferior Yes No - partial capsule incision Axillary nerve Yes Nodissection- mobilization

Referring to FIGS. 27, 27A, 27B, 28 and 29, the medial aspect of aglenoid implant device 10 is shown. The device is substantially circularin design, having a radius in the range of about 22 to about 46 mm.Shown also is a central anchor peg 12, the peg having a diameter rangeof 5 mm to 12 mm and an overall length of less than about 8 mm. Thecentral anchor peg shown has a concave surface 51 disposed to receive avolume of bone cement so as to enhance adhesion and retention of theimplant. Alternate configurations of this concave feature may include aplurality of annular ridges or grooves or other negative impressions inthe exterior surface of the peg.

In this embodiment the medial surface 16 of the implant device has beenconfigured to facilitate the flow of bone cement across and around themedial and circumferential aspects of said device so as to attainenhanced adhesion and stability of the glenoid implant after insertioninto the reamed cavity in the glenoid bone. The medial surface 16 hastherein a plurality of concentric grooves 18, and a plurality of radialflow channels 120 disposed to interconnect the concentric groovesforming a continuous flow path between each of the concentric grooves.The interconnecting channels 120 on the medial surface are furtherconnected to one or more circumferentially disposed channels 102 via theradial flow channels 120, thereby forming an open continuous flowpathway from the central anchoring peg 12, across the medial surface ofthe device 16 to and around the perimeter wall 20 of the glenoid implantdevice. This interconnected system of concentric grooves 18, radial flowchannels 120 and circumferential channel 102 is designed to accommodatethe flow of bone cement across the medial surface and around thecircumference of the glenoid implant device so as to assure enhancedadhesion of the implant device to and within the reamed glenoid cavityin the bone.

Further illustrated are bone cement wells 100 on the medial aspect ofthe implant device 16. These wells 100 may be used in conjunction withthe interconnected system of grooves 18 and radial flow channels 120 toaccommodate and accept any excess bone cement material which may migratewhile the glenoid implant device is being compressively inserted intothe reamed cavity in the glenoid bone.

While the cross sectional geometry of the flow channel system shown isgenerally rectilinear in nature it will be understood that various othergeometries can be used to further enhance performance, including but notlimited to those with negative tapers. FIG. 27A illustrates flowchannels with such a negative taper geometry. As illustrated in FIG.27A, the width of the channel at an opening 104 is less than the widthat the bottom of the channel 106. This enables the strength of the bondbetween the bone cement and the implant to be a function of both theadhesive bonding capabilities of the cement as well as the mechanicalinterlocking provided by the negative taper.

As illustrated in FIG. 27B, the bone cement 700 following implantationof the glenoid implant 10 will assume a concave configuration in which afirst surface corresponds to the medial surface of the implant 10, and asecond surface will assume the configuration of the reamed glenoidcavity. The bone cement shell will typically have a first layer 108extending across the distal end of the central anchoring peg 12. Thefirst layer 108 is connected via tubular wall 112 to a second layer 111.The radially inwardly facing surface of tubular wall 112 will preferablybe provided with at least one interlocking engagement structure such asa radially inwardly extending annular ridge (as illustrated) whichinterlocks with the complementary annular concavity 51 illustrated inFIG. 27. The second layer 111 generally comprises at least one surfacestructure 114 such as an annular ridge having a complementaryconfiguration to the at least one annular concentric groove 18.

The outer periphery of the second layer 111 is substantially circular inconfiguration, and carries an outer peripheral annular flange 116. Outerperipheral flange 116 may be provided with at least one radiallyinwardly directed projection or ridge 118, such as an annular ridgehaving a complementary configuration to one or more radially inwardlyextending annular channels 102 on the perimeter surface 20 of theglenoid implant device.

The hardened cement thus takes on the configuration of a concave shell,which corresponds to the mismatch in size and configuration between thesurface of the implant and the complementary reamed surface of theglenoid bone. The thickness of the cement shell may vary, potentiallydown to zero in spots, depending upon placement and size of the implantrelative to its corresponding reamed cavity in the glenoid bone.

FIG. 27B is an illustration demonstrating the adhesion and encapsulationof the glenoid repair implant device 10 within the reamed bone cavity,further illustrated is the bone cement 700, the bone cement adhering toor encapsulating the anchor peg 16, the medial surface of the implantdevice 16 and the perimeter groove 102.

In certain patients arthritis or other degenerative conditions may havecaused substantial wear and degeneration of the glenoid bone structure,resulting in a substantial deficiency of native bone and/or a loss ofthe natural concave structure of the glenoid joint. As a consequencethere may be insufficient native bone remaining to completely engage thecircumference of the glenoid implant device using the surgical methodspreviously described herein.

FIG. 30 illustrates a cavity reamed within glenoid bone, having a reamedsurface 203 for engaging the medial aspect of a glenoid repair implantand a perimeter wall 201 completely surrounding the reamed surface 203for the purposes of circumferentially engaging the complimentaryperimeter aspect of said repair implant, thereby encircling andconstraining the implant in the reamed bone cavity. FIG. 31 illustratessuch a cavity reamed into the glenoid structure of a patient havingworn, degenerated or otherwise deficient bone. In this instance theremay be insufficient native bone to create a fully enclosed cavity withinthe bone tissue. As a consequence the reamed surface 203 may not becompletely surrounded by the perimeter wall 201. As a result, there maybe insufficient native boney structure to assure positive location orfixation of the glenoid repair implant within the reamed bone cavity.

Referring now to FIG. 32, an alternate embodiment of the medial aspectof a glenoid implant device is shown. In this embodiment the medialsurface of the device 16 has thereon an axially extending boneengagement structure 110. This structure may be a continuous annularconstruct such as an axially extending circumferential flange or may bean interrupted or castellated construct as shown. Preferably, theengagement structure 110 will be symmetrically disposed about thecircumference of the implant 10 so that the implant may be positionedwithout regard for its rotational orientation within the bore.Alternatively, the axially extending bone engagement structure 110 maybe provided around less than the entire circumference, such as no morethan about 270°, or no more than about 180° of the circumference of theimplant. Measured in a direction parallel to the longitudinal axis ofthe post 12, the axial length of the sidewall which includes bothengagement structure 110 and the thickness of the implant at theperipheral edge will generally be at least about 3.5 mm, generally nomore than about 18 mm and typically within the range of from about 4.5mm to about 12 mm.

The illustrated engagement structure 110 is positioned at the peripheraledge of the implant 10. However, the bone engagement structure 110 maybe spaced radially inwardly from the outer peripheral edge of theimplant 110. In general, the engagement structure 110 will compriseeither a single annular ridge, or a plurality of projections. See, e.g.,FIG. 35. In either event, the engagement structure will generally residein a concentric circular orientation having a constant radius ofcurvature from the longitudinal axis of the implant. This permitsconvenient installation of the implant within a recess formed by areaming tool having a rotational axis of symmetry. A second or a thirdor additional axially extending bone engagement structures 110 may alsobe provided, spaced radially inwardly from the illustrated annularflange.

To accommodate the embodiment of implant device of FIG. 32 an alternategeometry of the reamed bone cavity may be created. Referring now to FIG.33 and FIG. 34, this complementary surface structure geometry isillustrated and described in connection with an implant having a singleperipheral annular flange bone engagement structure. In this embodimentthe reamed bone cavity has a reamed surface 203 disposed to engage themedial surface of the glenoid repair implant. This surface is furtherprovided with a receiving groove 204 reamed below the plane of thesurface 203 to receive the peripheral anchor 110 of the glenoid repairimplant (see FIG. 32). The groove within and below the surface of thebone tissue may be produced by reaming, either by means of a reamer toolhaving a complimentary cutting profile which simultaneously produces thesurfaces 203, 205, 206 and 207 or by means of 2 reamers, one whichproduces surface 203, and another which subsequently produces surfaces205, 206 and 207. The engagement of the perimeter construct 110 of theglenoid repair implant (FIG. 32) with the receiving bone groove 204within the glenoid bone structure enables complete circumferentialengagement of the implant repair device within the glenoid bonestructure to assure positive location and engagement of the implantdevice with and within the native bone tissue. The glenoid repairimplant may be fixed to and within the reamed cavity by means of bonecement or other fixation means.

Significant posterior wear and bone loss is common in patients withosteoarthritis, and significant medial wear and bone loss is common inpatients with inflammatory arthritis. Combinations of different wearpatterns further complicate surgical decision making. Since all currentmodels of glenoid implants lay on the surface of the disfigured, erraticjoint surface, it is often impossible to provide secure fixation withcurrent implants that can withstand the stresses of a rotating,elevating, translating humeral head throughout a full array of shouldermotions. Therefore, surgeons often abandon placement of a glenoidimplant in deficient bone. In other instances, the surgeon may elect tocreate a bone graft by cutting out part of the humeral head or resectinghip bone in order to provide a wedge of bone to be secured onto theglenoid bone tissue with screws or other means of fixation. Thereafter,a glenoid implant can be placed through the graft wedge. This procedureis extremely difficult to perform, even by highly skilled surgeon, thereis a high degree of subjectivity and the rate of complications is high.Complications may include implant loosening, screw breakage orloosening, graft resorption, neurovascular injury and death.

Further, in patients with substantial bone wear, degradation, ordeficiency there may be a need to restore the natural angulation of thearticulating surface so as to recreate the natural geometry of theglenoid to humeral interface so as to restore normal mobility and rangeof motion to the joint. Current practices include the use of a bonegraft material in conjunction with prosthetic implant devices, the bonegraft material being implanted between the prosthetic and native bonetissue in an attempt to reconstruct the volume and angulation of thebony structure to receive and support the prostheses.

Proposed herein is an alternate embodiment of a glenoid implant devicewhich can be implanted in a minimally invasive manner into bonedeficient patients which allows for the restoration of naturalangulation and geometry at the humerus to glenoid interface, does notrequire the use of bone graft material and does not require the use of along keel or anchor peg system.

Referring now to FIG. 36 and FIG. 37 a glenoid repair implant device isdescribed, the implant device 300 having a generally cylindricalperimeter concentrically disposed about a central axis which iscoincident with centerline CL. A medial surface 16 is configured tocontact a reamed surface within glenoid bone and a concave articulatingsurface 14 is configured to contact the articulating surface of ahumeral bone, or humeral bone prosthesis. The ‘plane’ of thearticulating surface 14 is offset from the plane of the medial surface16 by an include angle A, resulting in a wedge shaped cylindrical form.Angle A represents the corrective angle necessary to restore thefunctional angulation of the concave glenoid articulating 14 surfacewith respect to the reamed surface of the cavity within the bone tissue(203) of FIG. 30. Angle A is generally within the range of 5 degrees to30 degrees.

The position of the neutral or resting position of the humeral toglenoid interface, Point R, may be adjusted by varying the nominalthickness of the implant device, d3 This thickness is typically in arange of 3 mm to 15 mm, depending upon the extent of the deficiency ofnative bone and the corrective angle necessary to restore functionalangulation to the glenoid joint.

Referring specifically now to FIG. 36, shown is a center section view ofthrough a circular glenoid implant. The section view shows the maximumheight of the implant Dmax and the minimum height of the implant Dmin,both measured from a common reference such as the medial surface of theimplant device 16. The medial surface 16 is perpendicular to thecenterline of the implant device CL. The ‘plane’ of the articulatingsurface 301 is offset from the plane of the medial surface 14 by thecorrective angle A. The offset angle of the plane of the articulatingsurface, angle A, is defined as the maximum angle created by theintersection of a perpendicular 302 to the centerline of the device CLand the chord line 304 produced by connecting point P and point Q.Points P and Q are the respective maximum and minimum thicknessdimension of the implant, measured in an axial direction, at theirrespective maximum radial distances from the device centerline CL, asmeasured from a constant reference such as the medial surface of theimplant device 16.

The combination of a circular implant device with this offset angularsurface construction enables the surgeon to accurately orient theprimary axis of the articulating surface within the wound by rotatingthe implant device about the centerline of the device CL while it isin-situ in the reamed cavity of the glenoid bone. Referring to FIG. 37A,it is evident that point P can be positioned at any radial location byrotating the implant device about the centerline CL, thereby providinginfinite planar orientation of the articulating surface 14 and enablingthe surgeon to orient the plane of the glenoid implant so as tooptimally restore the functional angulation of the glenoid jointstructure.

As an aid to the surgeon, one or more indicator marks can be included onthe device, this indicator being visible when the device is implantedwithin the reamed cavity in the glenoid bone. FIGS. 37A and 37Billustrate alternate embodiments of indicator markings. FIG. 37Aillustrates a single indicator mark on the articulating surface and/orthe peripheral edge of the implant, which indicates the apex of thearticulating surface, point P. FIG. 37B illustrates a plurality ofindicia radially orientated around the perimeter of the device, allowingfor metered in-vivo rotational adjustment of the device to orient theapex of the implant at the optimal position within the reamed glenoidcavity. Indicia markings may be manufactured by many processes whichproduce a positive or negative feature on the device or which produce agraphic on or within the device, including but not limited to, lasermarking, printing, injection molding and machining.

Referring now to the embodiment of FIG. 38, the articulating surface 14is defined as a surface of revolution created by rotating an arc ofconstant radius R1 about an axis of rotation 400, this axis of rotationbeing offset from the centerline of the device CL by angle A andintersecting the centerline of the device CL at a prescribed distancefrom the medial surface D3. In the embodiment of FIG. 38 the radius ofthe arc of rotation has an origin (0) located on the axis of rotation,thereby producing a spherical articulating surface.

In the foregoing illustration, a line drawn perpendicular to the axis ofrotation 400 at the articulating surface 14 (e.g., a tangent) will beangularly inclined relative to the centerline by an Angle A. Angle A maybe at least about 5°, 10°, 15°, or 20° or more, depending upon thedesired clinical performance.

In an alternate embodiment, shown in FIG. 39, the origin O of theconstant radius arc is offset contra-laterally from the axis of rotation400 of the concave surface. In this embodiment the articulating surfaceis defined as a surface of revolution, created by sweeping an arc ofconstant radius (R1) about the axis of rotation 400 to produce a nonspherical articulating surface of constant radius R1. FIG. 40 is a sideelevational cross sectional view of the articulating surface created bythe geometrical construct of FIG. 39, illustrating that the surfaceconstruct has an apex at point R. FIG. 41 is a specific embodiment ofthis construct for a glenoid implant having a cylindrical diameter of 31mm, the radius of the arc of revolution being 90 mm and being offsetcontra-laterally from the axis of rotation by 7.78 mm to produce aconcave articulating surface with a depth of 3 mm at the devicecenterline.

In general, glenoid implants in accordance with the present inventionwill often have a lateral offset distance within the range of from about2 mm to about 18 mm, and a radius for the arc of revolution within therange of from about 30 mm to about 200 mm and have a circular diameterof 20 mm to 55 mm.

FIG. 42 is a perspective view showing a cross section through anarticulating surface generated by the specific geometry of FIG. 41, theplane of the articulating surface 14 being offset from the plane of themedial surface 16. FIG. 42 further shows the articulating surfacegenerated by the specific construct of FIG. 41 and identifying the axisof rotation (400), the device centerline CL, the articulating surface ofconstant radius (R1) created by revolving this arc 360 degrees about theaxis of rotation (400) and the resultant apex of the articulatingsurface, occurring at Point R.

There remains ongoing debate as to the relative benefits of aconstrained or non-constrained shoulder replacement system. Aconstrained system is a specific combination on a prosthetic humeralhead and glenoid implant pair, wherein there is a precise andconstrained fit between the humeral head and the glenoid implant device,limiting relative motion of the two components to pure sphericalarticulation. In non-constrained systems the spherical diameters of thehumeral head prosthesis and that of the glenoid implant device aredeliberately mismatched, the glenoid implant having a larger diameterthan the humeral head. In this construct the humeral head can articulatespherically and can translate across the surface of the glenoid implantin an unconstrained manner.

Published literature discusses various biomechanical benefits andlimitations of both systems. Both systems offer significant benefits andlimitations and several attempts have been made to develop hybridsystems. U.S. Pat. No. 5,928,285 to Bigliani et Al. discloses a systemwherein the glenoid surface is defined by 2 or more tangentiallyintersecting radii, with the central radius being matched to that of thehumeral head and the lateral radii of the glenoid being larger than thatof the humeral head. The cited benefit being that in the central neutralposition the pair acted as a constrained pair and when the humeral headtranslated laterally onto a glenoid surface of larger radius size thanthe head, the system mimicked the characteristics of an un-constrainedsystem. In this construct it is necessary to match the humeral headradius to that of the glenoid, thereby requiring that matched pairs beimplanted within the patient. U.S. Pat. No. 6,875,234 to Lipman et al.discloses a system wherein the glenoid articulating surface is comprisedof 2 non tangential radii, the radius in the central neutral zone beinglarger than that of the humeral head and the glenoid radius lateral tothe neutral zone being of a smaller size and being non-tangential to theradius of the neutral zone. In this configuration the humeral head isfree to articulate and translate within the central neutral zone andbecomes more constrained as the humeral head translates laterally acrossthe glenoid surface.

Of further note is that fact that in unconstrained systems the contactbetween the humeral head and the articulating glenoid surface isessentially a point contact. This increases load transfer within andthrough the glenoid implant and has been shown to negatively impact wearand permits loosening of the glenoid repair implant over time.

Referring now to FIG. 43, there is illustrated an enlarged crosssectional view of the articulating surface of the glenoid repair implantconstruct shown in FIG. 41. FIG. 43 further illustrates a representationof various diameter humeral heads, ranging in size from 20 mm to 60 mmengaging the articulating surface 14 of the glenoid repair implantdevice 10. Humeral heads in current use range from 36 mm to 60 mm. FIG.43 illustrates that the geometry of the articulating surface resultingby generating a surface of revolution in a manner described by FIG. 41can accommodate a humeral head of any size. Further, this offset surfacegeometry construct results in full circumferential contact between thehumeral head and the glenoid articulating surface while in the neutralposition. FIG. 43 illustrates the chords C20, C40, C50 and C60 which arethe diameters of the circumference of contact between the articulatingsurface of the glenoid repair device and the corresponding humeral headshaving diameters measuring 20 mm, 40 mm, 50 mm and 60 mm respectively.This circumferential contact: 1) increases the surface area of contactbetween the glenoid surface and humeral head implants significantly, ascompared to an unconstrained system with a single point of contact; 2)results in a uniform circular distribution of loads within and throughthe glenoid implant; 3) distributes loads more uniformly around thecentral anchor peg so as to minimize offset loads which can loosen theimplant; and 4) induces the humeral head to return to the neutralposition after any translational movement across the articulatingsurface 14, resulting in an implant system with self centeringcharacteristics.

In FIG. 43, the geometry of the articulating surface 14 clearlydemonstrates an apex of non-contact at Point R. As a consequence of theoffset surface geometry construct there is never contact between thehumeral head or the glenoid articulating surface 14 in an area of thesurface surrounding point R, thereby creating a zone of non-contacthaving a diameter approximately equal to the chord length discussedabove which depends upon the curvature of the humeral head. With thisoffset surface construct it is therefore conceivable that thearticulated surface of the glenoid implant could be discontinuous inthis region, allowing for the inclusion of a port or hole passingthrough the Glenoid articulating surface into the central anchor peg toaccommodate secondary fastening or securement of the implant device inthe final in-vivo location. Such fasteners could include bone screws,staples, expanding pegs or other axially or rotationally adjustabledevices which induce mechanical engagement to the native bone. Thisconstruct offers substantial advantage over current devices in whichthere is contact between the humeral head and any discontinuity in thearticulating surface.

FIGS. 43A and 43B illustrate exemplary embodiments of one suchconstruct. In both embodiments there is an open lumen or channel betweenthe offset articulating surface 14 and the medial surface 16, theopening on the articulating surface being located in the zone ofnon-contact.

The exemplary embodiment of FIG. 43A illustrates a glenoid repair devicewhich does not have an integral central anchor peg. In this specificembodiment the peg is replaced by a removable mechanical fastener 600such as a bone screw, barbed peg, staple or other device which isinserted through the central access channel into the native glenoid bonepassing from the articulating surface 14 through the medial surface 16and into the native bone structure after the repair implant has beeninserted into the reamed receiving cavity in the bone.

Referring once again to FIG. 32, an exemplary embodiment of the medialaspect of a glenoid repair implant device is shown. In the configurationshown a segmented central anchor peg is shown, having an annularconstruct with a hollow core 132 and the annular aspect being dividedinto a plurality such as two or three or four or more discrete axiallyextending finger elements 130. In this embodiment the external diameterof the anchor peg (E) is larger than the internal diameter of thecorresponding receiving hole drilled in the native glenoid bone. Uponinsertion of the anchor peg into the receiving hole the finger elements130 flex elastically radially inwardly into the hollow core 132producing a radially outwardly directed compression force to be exertedin the native bone tissue. Such a segmented construct can bemechanically enhanced and complimented by a mechanical feature whichengages the finger elements or native bone within or through the hollowcore 132.

Referring now to FIG. 43B in combination with FIG. 32, the exemplaryembodiment illustrated in FIG. 43b has an open access channel 600between the articulating surface 14 and the medial surface 16 of thedevice and further passing axially through the segmented central anchorpeg, the segmented anchor peg being of a construct similar to thatillustrated in FIG. 32. A mechanical fastener 601 is inserted in anaxial direction through the opening of the central access channel 600 atthe articulating surface of the implant device 14, engaging the internalsurfaces of the anchor peg segments 610. As the fastener progressesaxially into the channel, the anchor peg segments 130 are induced toflex radially outwards causing the external surfaces of the anchor pegsegments 620 to impinge into the native cancellous bone of the glenoidstructure below the cortical bone surface. This impingement anchors theimplant within the native bone of the glenoid structure. The radiallyoutwardly facing surfaces of the segments 620 may be provided with anyof a variety of barbs, ridges, roughened surface textures or other boneengagement feature.

The mechanical fastener illustrated in FIG. 43b is a threaded device,having an external thread 630 which mates with an internal thread 640within the glenoid implant device. Various embodiments of the mechanicalfastener 601 may be used, including but not limited to, screws, barbedrods and split pegs.

The mechanical fastener 601 includes a proximally facing surface 650,which, following installation, will face the humeral ball. Surface 650is preferably recessed beneath the adjacent articulating surface 14.This may be accomplished by providing a recess 652 into the articulatingsurface 14 to receive a head on which the surface 650 resides.Alternatively, the mechanical fastener 601 may comprise a threaded bodyhaving a relatively constant outside diameter throughout its axiallength, such that it can be axially advanced into the access channel 600until the proximally facing surface 650 is beneath the level ofarticulating surface 14.

In an embodiment in which mechanical fastener 601 is rotated intoengagement with segments 610, the proximal surface 650 is provided witha mechanical interfit coupling, for removably cooperating with a drivertool. The coupling may comprise a recess such as slot or polygon such asa triangle, square, pentagon or hexagon. Implants in accordance withthis aspect of the invention may be provided in a kit which includes adriver tool, such as an Allen wrench, or other specialized screwdriverto rotationally engage the mechanical fastener 601. The driver tool maycomprise an elongate tubular body, having a lateral bend such as a 90°bend at its distal end. A rotatable tip is carried by the distal end,and configured to complement the geometry of the engagement structure onmechanical fastener 601. The rotatable tip is connected via the centrallumen to a proximal control, which may be rotated by the clinician torotate the mechanical fastener 601 into place. Mechanical connectionbetween the proximal control and the distal rotatable tip may comprise aflexible cable extending through the central lumen, or a torque rodwhich may be provided with suitable gears at the point of the bend totranslate rotational force from the longitudinal axis of the tool to thetransverse axis of the rotatable tip.

In general, any of a variety of structures may be utilized to convertaxial proximal or distal movement, or rotational movement of an activeengagement mechanism, to produce a radially outwardly directed advanceof one or more bone engaging components carried by the post 12, tofacilitate bone engagement.

Referring now to FIG. 45, an alternate embodiment of the medial aspectof a glenoid repair implant device 16 is shown having yet anotherexemplary embodiment of a segmented central anchor peg construct. Inthis embodiment the central anchor peg has an external diameter F,within the range of from about 10 mm to 20 mm. The relatively wideanchor peg is intended to isolate and distribute the forces transmittedto the glenoid implant device by the humeral head while articulatingwithin the normal neutral region of the shoulder joint.

The segmented anchor peg of this embodiment may further be provided witha hollow core 132, capable of accepting and retaining supplemental bonegraft material so as to promote osteointegration of the glenoid repairimplant within the native bone. Radially outwardly actuatable barbs,spikes or other bone engagement structures may also be provided asdiscussed above.

Referring now to FIGS. 43 and 45 in combination, a specific embodimentof a glenoid repair device is described, the device having an offsetarticulating surface construction of FIG. 43 combined with the largediameter anchor peg construct of FIG. 45. In this embodiment, diameter Fof the glenoid repair implant (FIG. 45) is larger than the maximum chordof contact which can occur for the corresponding humeral implant therebyassuring an optimal distribution of forces within the glenoid repairimplant as a result of the circumferential line of contact and optimaltransfer of loads through the glenoid repair implant into the nativebone structure through the structure of the central anchor peg.

Humeral Head Cutting Jig

Referring now to FIGS. 17-19, humeral head cutting jig 26 according tothe present invention is a simple, low profile humeral cutting jig thatcan be a full circle or part thereof. Cutting jig 26 can be secured tothe humeral head using K-wires, pins, or screws 27 and is removed aftercompletion of humeral head resection. Cutting jig 26 includes handleportion 28.

The cutting jig should be placed along the anatomic neck of the humeralhead. Osteophytes which obscure the junction of the humeral head andhumeral shaft should be removed in order to accurately mark the level ofthe anatomic neck circumferentially from anterior to inferior toposterior. The cutting jig can be fixed to the humerus using wires,pins, or screws at the appropriate angle and version as determined bythe surgeon. The rotator cuff should be carefully protected withretractors, and then the humeral cut is performed using an oscillatingsaw or osteotome along the surface of the cutting jig.

The cutting jig can be manufactured using metal.

Humeral Implant

Referring now to FIGS. 20A-D, humeral implant prosthesis 38 according tothe present invention includes stem 40 having elongated portion 42optionally including collar 44, which prevents humeral implantprosthesis 38 from embedding too deeply in the humerus. Humeral implant38 also includes flange (fin) 46, which aids in the fixation of the stemin the humerus and prevents rotation of humeral implant in the humerus.There may be just one lateral flange (fin), or there may be two or threeflanges (fins), e.g., with one lateral, one anterior, and one posterior.The stem length is preferably less than about 70 mm, and the stem widthis preferably less than about 40 mm (preferably about 30 mm).

At the distal end of the stem, there is rounded portion 48 and at theproximal end of the stem is a support surface extending radially fromthe stem. The support surface has an upper planar surface 50 thatincludes bore (hole with morse taper) 52 extending inwardly from the topplane thereof, and which is adapted to be engaged by a humeral headimplant with a morse taper extension. Modular humeral head implants(both concentric and eccentric) are known in the art (see, e.g., U.S.Pat. Nos. 4,865,605; 5,314,479; 5,462,563, and 5,489,309, and U.S.Patent Application Nos. 2004/0167629, 2004/0064187; each of which isincorporated herein by reference). The plane of upper planar surface 50is preferably between about 45 degrees and about 60 degrees to the axisof the stem.

The entire stem portion, or a portion thereof, is preferably coated witha porous material for aiding in the fixation of the humeral implant inthe humerus for a press fit stem. The implants made for cement fixationcan have a smooth surface or a roughened, textured surface.

Humeral implant 38 can be rectangular or rounded edges, but issignificantly thinner anterior to posterior than medial to lateral. Itwill have a morse taper for securing a standard humeral head implant.

An advantage of the humeral implant of the present invention overcurrent humeral implant stems is that the humeral implant of theinvention is significantly shorter than most current stems, which areabout 70-115 mm in length. Because the humeral implant is shorter, itsaves bone because of the narrow metaphyseal area required forimplantation. The present humeral implant is less than 70 mm in length,preferably about 60 mm in length, and less than 40 mm anterior-posteriorwidth (preferably about 30 mm). Fixation of the present humeral implantdepends upon good interference fixation in the medial-lateral plane whenpress fit (similar to some current total hips). The humeral implant canbe fixed using a bone cement, such as polymethylmethacrylate (PMMA) or acompatible fixation material, or it can be press-fit.

The invention will now be described by the following examples. Thefollowing examples are meant to illustrate the invention. They are notmeant to limit the invention in any way.

EXAMPLES Example 1

A 62 year old woman presented with progressive, debilitating shoulderpain from osteoarthritis, which she had experienced for approximately 15years. She had constant pain (rated 9/10) and difficulty washing herhair, fastening her bra, lifting a cup of coffee, and performing otherdaily activities. The preoperative radiographs and CT scan showed severeshoulder arthritis and glenoid bone loss that would preclude the use ofa keeled or pegged glenoid implant. There was concern that ahemiarthroplasty procedure (replacement of the humeral ball, which wouldleave the arthritic glenoid socket bare) would not relieve the patient'spain.

A total shoulder replacement using an inset glenoid implant of theinvention and a standard humeral implant was performed. The smaller sizeand circumferential fixation of the inset glenoid implant allowed safeplacement of the prosthesis within the confines of the patient'sdeficient glenoid cavity.

The deficient glenoid vault was not fractured and the fixation was verystable. The patient had 100% relief of pain only 1 week after surgery.Her own assessment of shoulder function 4 weeks after surgery was 56% ofnormal (American Shoulder and Elbow Society validated outcome score[ASES score]) was 56 compared to 16% of normal before the surgery (ASESscore 16).

This surgery was performed through the “mini-incision total shouldertechnique” described above. FIG. 25 shows the surgical incision 4 weekspost-operatively. FIG. 24, which shows a more typical total shoulderincision, clearly demonstrates the improved cosmetic appearance andreduced incision size achieved using the “mini-incision total shouldertechnique” described above. FIGS. 21-23 are intraoperative pictures ofthe implanted inset glenoid prosthesis in this patient.

Example 2

An 81 year old woman presented with severe shoulder pain and stiffness.She had severe shoulder arthritis with medial wear causing glenoid boneloss. Her own assessment of shoulder function was 25% of normal(American Shoulder and Elbow Society validated outcome score [ASESscore] was 25).

A total shoulder replacement using an inset glenoid implant prosthesiswas performed. Two months after her surgery, the patient had no pain andexhibited improved function. Her own assessment of shoulder function was70% of normal (American Shoulder and Elbow Society validated outcomescore [ASES score] was 70).

While the invention has been described in connection with specificembodiments thereof, it will be understood that it is capable of furthermodifications and this application is intended to cover any variations,uses, or adaptations of the invention following, in general, theprinciples of the invention and including such departures from thepresent disclosure that come within known or customary practice withinthe art to which the invention pertains and may be applied to theessential features hereinbefore set forth.

What is claimed is:
 1. A glenoid implant, comprising: a circular body, having a medial surface, an articulating surface, a peripheral edge, and a central axis; a post on the medial surface, disposed concentrically on the central axis; and a first thickness measured in the axial direction at a first point on the peripheral edge, and a second thickness measured in the axial direction at a second point on the peripheral edge spaced apart from the first point by 180 degrees; wherein the first thickness is at least about 125% of the second thickness, wherein the articulating surface comprises a non-spherical shape defined by a complete rotation of an arc of a first, constant radius about an axis of rotation passing through the longitudinal midpoint of the articulating surface.
 2. A glenoid implant as in claim 1, wherein the first thickness is at least about 150% of the second thickness.
 3. A glenoid implant as in claim 1, wherein the first thickness is at least about 200% of the second thickness.
 4. The glenoid implant of claim 1, wherein the axis of rotation is offset from the central axis.
 5. The glenoid implant of claim 1, wherein the constant radius is between approximately 70 and 100 mm.
 6. The glenoid implant of claim 1, wherein a radius of the circular body is between about 10 and about 27 mm. 